APalutamide and stEReotactic Body Radiation Therapy for Low Burden Metastatic Hormone senSItive Prostate Cancer, a rANdomized Trial - PERSIAN
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Complete biochemical response
研究概览
简要总结
Final results from TITAN trial showed that apalutamide plus ADT improved OS in a population of patients with metastatic hormone sensitive prostate cancer (mHSPC), if compared to ADT alone. However, stereotactic body radiotherapy (SBRT) showed to improve outcomes of oligometastatic patients if compared to systemic therapy alone within modern randomized trial, including a mixed cohort of different pathologies. However, there are no trials specifically exploring the benefit offered by SBRT in oligometastatic mHSPC treated with Apalutamide if compared to Apalutamide alone associated to Androgen deprivation therapy. Thus, a randomized trial was designed to test specifically the hypotesis that SBRT will improve outcome in a selected population of oligometastatic mHSPC treated with Apalutamide and ADT, undergoing baseline staging according to local reimbursability.
详细描述
Prospective Phase II randomized superiority study, open label, multicentric. Patients with Oligometastatic hormone sensitive prostate cancer defined as presence of ≤ 5 non-visceral metastatic lesions and treated with androgen deprivation treatment associated with Apalutamide will be randomized to receive standard systemic treatment alone or concomitant SBRT on all sites of metastatic disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients who have signed written informed consent
- •Adult patients ≥ 18 years
- •Oligometastatic hormone sensitive prostate cancer defined as presence of ≤ 5 non-visceral metastatic lesions *, **
- •All lesions must be amenable to SBRT in judgment of treating radiation oncologist ***
- •Patients with metastatic recurrence after previous radical prostatectomy or definitive radiotherapy will be included in the trial, provided that radical approach on prostate is administered
- •Androgen deprivation therapy (ADT) started ≤ 6 months before enrollment
- •Patients should be eligible to Apalutamide treatment
排除标准
- •Presence of visceral disease
- •De novo metastatic disease
- •Any contraindication to the use of Apalutamide
- •Any condition for which, in the opinion of the treating physician, SBRT should not be proposed or could be contraindicated
结局指标
主要结局
Complete biochemical response
时间窗: 6 months after treatment start.
Rate of patients with complete biochemical response (PSA \< 0.2 ng/ml)
次要结局
- Cancer Specific Survival(2 years after treatment)
- Freedom from biochemical progression(2 years after treatment)
- Freedom from radiological progression(2 years after treatment)
- Rate of adverse events(2 years after treatment)
- Overall Survival(2 years after treatment)
- Health related quality of life(2 years after treatment)
研究者
Lorenzo Livi
Full Professor
Azienda Ospedaliero-Universitaria Careggi